NCT00520286

Brief Summary

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

April 7, 2017

Completed
Last Updated

April 7, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

August 23, 2007

Results QC Date

December 30, 2016

Last Update Submit

February 23, 2017

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

  • Abstinence (Week 1 - 12)

    Number of participant who abstained from methamphetamine from weeks 1 through 12

    Weeks 1 - 12

Secondary Outcomes (1)

  • Reduction of Craving

    21 days

Study Arms (2)

Modafinil

ACTIVE COMPARATOR

Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks

Drug: Placebo

Interventions

ModafinilDRUG

200 mg or 400 mg /daily

Modafinil
PlaceboDRUG

Placebo / daily

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be between the ages of 18 and 65
  • Methamphetamine dependent as defined by DSM-IV criteria
  • Must be in good general heath with a history of methamphetamine use at screening
  • Must be able to provide written informed consent
  • If female and of child bearing potential, must agree to use birth control.

You may not qualify if:

  • Please contact site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

South Bay Treatment Center

San Diego, California, 92105, United States

Location

Matrix Institute on Addictions

Tarzana, California, 91356, United States

Location

Torrance Site

Torrance, California, 90502, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80220, United States

Location

John A. Burns School of Medicine

Honolulu, Hawaii, 96813, United States

Location

Powell Chemical Dependency Center

Des Moines, Iowa, 50316, United States

Location

START Research and Treatment

Kansas City, Missouri, 64131, United States

Location

Salt Lake City VA Medical Center

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

  • Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12.

    PMID: 21840138RESULT

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Liza Zeinert
Organization
National Institutes of Health
liza.zeinert@nih.gov
301-443-1138

Study Officials

  • Ahmed Elkashef, M.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

April 7, 2017

Results First Posted

April 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)